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Clinical Biomed yr2 > calibration and quality control > Flashcards

calibration and quality control Flashcards

1
Q

what is calibration

A

process proving link between nstrument signal and concentration of the anayte
ensues results obtained on local analyser match defined reference method

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2
Q

what is an assay working range

A

senstivity, minumum amunt of analyte distinguishable and its upper limit before exhaustion

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3
Q

when is single point calibration used

A

with a linear working range

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4
Q

sample blank

A

no sample but only reagents

want to measure everything above the backgrund

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5
Q

heterogenous analytes

A

mixture of releated molecules

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6
Q

traceability

A

an unbroken chain of comparisons of measrements leading to a known reference value

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7
Q

primary reference procedure

A

fully understood procedure of highest analytical quality

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8
Q

seconddary reference methods

A

uses in hopsitals to measure concentrations in secondary samples

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9
Q

outline process of calibration

A

master calibrant mde by manufactuers
this is measured by te AAS method
assat calibrated using secndary calibrant
this then referenced against secondary reference procedure
then caloibrated with pure analyte
then measured by primary calibratory which everything in the world is calibrated against

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10
Q

ICQ

A

internal quality control
assurance that results are comparable to the previous days an everything is accurate
patient means should be steady

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11
Q

types of assay erry

A
  • large changes in bias due to calibration or reagent error

- slow drift in assay results from age of reagents or equipment

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12
Q

internal QC controls

A

minimal vial to vial control variation

eg dont use the same manufacturers control and machine as there could be errors

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13
Q

how should new QCs be handled?

A

calibrants run in with old one to check for a differene

determien mean and SD of results and check for rejection rules: westgard rules

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14
Q

whats rejected on a control chart?

A

any mean below -3SD

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15
Q

what is external quality assesment

A

provides assurance that resultsare comparabe between laboratores
documentation of long term performance

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16
Q

whats the role of lboratory accreditation

A

ensure procedures are in line with legistaltion and best practice
involves inspectios and standards

17
Q

total quality management

A 
planning
lab practice
control
inernal and external
aassurance
imporovements
18
Q

analytical sensitivity definition

A

detection limit of the experiment

the smallest amount of material that the experiment can detect

19
Q

analaytical specificity

A

referes to if any other similar chemicals will interfere with the test

20
Q

what is POCT

A

point of care testing

- bedside, near patients extralaboratories and decentralised tesitng

21
Q

examples of POCt

A

urine dipsticks
pregancy estses
diabetets blood tests

22
Q

role of mini-analysers

A

small intruments to carry out focusses tests in A and E or intensive care units
- RBC/WBC counts, troponin in heart attacks blood gasses and drug abuse

23
Q

what is a microanalysers

A

singe analysis on a single sample
found in A/E and ICU
eg rapid test for Ddimers in a pulmonary embolism

24
Q

benefit of POCt

A

speed and ease of diagnosis
easy intervention
decreases doctor time with patients
efficient management of patients

25
Q

drawbacks of POCt

A
  • cost is bigger per test

- issue with reproducability

26
Q

why is cost an issue with POCt

A

price per test bigger

POCT needs to be attractive by reducing the overall cost and considering the benefits to the patient

27
Q

why is reproducability an issue for POCT

A

labs are tighly controlled bybesdside tests are not

lots of variability in results

28
Q

what varibility factors need to be considered with POCT

A
  • stroage
  • sample type
  • result calibraation
  • analytcal errors
  • untrained staff
29
Q

regulations on POCT

A 
reagent manufacturing
calibration
GLP
trained staff
understading of results
quality manamgement of results
30
Q

issues with POCT training

A
  • large number of users
  • not much knowedge on them
  • environment not suited to test
  • health and safety issue
31
Q

what should POCT training look like

A 
pratical and theorietical geuidance
SOPs
documentation
supervsison
checks

Clinical Biomed yr2 (22 decks)

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